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Posted On: 11/17/2023 1:51:19 PM
Post# of 148863
Respert: As always, I enjoyed and appreciated your sage analysis. While I fully agree with your conclusion that our reddit friend's conjecture regarding the proper interpretation of the successful transfer of LL manufacturing technology is misguided, I do find the sentence structure of the subject 2nd paragraph of the the Nov 3 shareholder letter interesting.
As you point out, the 2nd paragraph recites historical achievements. of the company. The 1st sentence references transitioning LL from a single indication to a platform drug. The 2nd references all the clinical trials that CYDY has conducted and the associated data collected.. But the 3rd sentence, re the transfer of LL manufacturing technology, strikes me as both out of place chronologically and superfluous. That transfer to Sansung happened before the clinical trials were conducted and was inherent to their occurrence --- which makes me wonder if the key words in the 3rd sentence might actually be "clinical trials and potential FDA approvals." And that possibility brings me to the portion of your analysis that I don't readily share.
You also disagree with our reddit friend's other main argument -- that the FDA will grant emergency authority for LL to treat a HIV sub population of patients. As you may recall, I offered the same emergency authority theory in a post a few months ago. At the time, I hedged my guesstimate by conceding that nothing ever seems to work out for CYDY, least of all, its dealings with the FDA. Nothing has changed in that regard since then, but neither has anything changed regarding the basis upon which my opinion was formed.
Several months ago, CYDY reported that the most recent FDA request for more info and data involved a benefit-risk analysis of LL for HIV patients, input from HIV and gay rights key opinion leaders, and a protocol for a HIV clinical trial. As ohm pointed out in a post yesterday, a clinical trial protocol has nothing to do with a clinical hold and neither do the other requested items. But all of the latest requested items would be entirely appropriate and no doubt useful in exercising the FDA's emergency use authority regulations and guidelines, assuming the requested trial protocol actually relates to a phase 4 confirmatory trial. Moreover, it strikes me as unlikely that the FDA would simply invite, let alone require, a drug company to submit a lengthy trial protocol unrelated to the emergency use authority process or that a resubmission of the accursed BLA is even possible.
So -- getting back to the final words of the 3rd sentence of paragraph 2, what if the point of incongruously referencing "potential FDA approvals" in a paragraph devoted to historical accomplishments was intended as an affirmation that CYDY still has the manufacturing capability to provide LL to a large sub population of HIV patients. That reading would be both chronologically appropriate and highly pertinent as a historical achievement. Just saying.
While I'm not sure how much simply lifting the hold will move the sp needle, I do think that if the emergency use authority scenario set forth by me and our reddit friend were to come to pass, I suspect that development would provide a significant jolt to said sp.
On the other hand, good and respected friend, I freely concede that the history of CYDY's relationship with the FDA bodes strongly in support of your dismissal of the emergency use approval theory. Nevertheless, I'm still on board with that ship and accept the risk of going down with it.
All the best.
As you point out, the 2nd paragraph recites historical achievements. of the company. The 1st sentence references transitioning LL from a single indication to a platform drug. The 2nd references all the clinical trials that CYDY has conducted and the associated data collected.. But the 3rd sentence, re the transfer of LL manufacturing technology, strikes me as both out of place chronologically and superfluous. That transfer to Sansung happened before the clinical trials were conducted and was inherent to their occurrence --- which makes me wonder if the key words in the 3rd sentence might actually be "clinical trials and potential FDA approvals." And that possibility brings me to the portion of your analysis that I don't readily share.
You also disagree with our reddit friend's other main argument -- that the FDA will grant emergency authority for LL to treat a HIV sub population of patients. As you may recall, I offered the same emergency authority theory in a post a few months ago. At the time, I hedged my guesstimate by conceding that nothing ever seems to work out for CYDY, least of all, its dealings with the FDA. Nothing has changed in that regard since then, but neither has anything changed regarding the basis upon which my opinion was formed.
Several months ago, CYDY reported that the most recent FDA request for more info and data involved a benefit-risk analysis of LL for HIV patients, input from HIV and gay rights key opinion leaders, and a protocol for a HIV clinical trial. As ohm pointed out in a post yesterday, a clinical trial protocol has nothing to do with a clinical hold and neither do the other requested items. But all of the latest requested items would be entirely appropriate and no doubt useful in exercising the FDA's emergency use authority regulations and guidelines, assuming the requested trial protocol actually relates to a phase 4 confirmatory trial. Moreover, it strikes me as unlikely that the FDA would simply invite, let alone require, a drug company to submit a lengthy trial protocol unrelated to the emergency use authority process or that a resubmission of the accursed BLA is even possible.
So -- getting back to the final words of the 3rd sentence of paragraph 2, what if the point of incongruously referencing "potential FDA approvals" in a paragraph devoted to historical accomplishments was intended as an affirmation that CYDY still has the manufacturing capability to provide LL to a large sub population of HIV patients. That reading would be both chronologically appropriate and highly pertinent as a historical achievement. Just saying.
While I'm not sure how much simply lifting the hold will move the sp needle, I do think that if the emergency use authority scenario set forth by me and our reddit friend were to come to pass, I suspect that development would provide a significant jolt to said sp.
On the other hand, good and respected friend, I freely concede that the history of CYDY's relationship with the FDA bodes strongly in support of your dismissal of the emergency use approval theory. Nevertheless, I'm still on board with that ship and accept the risk of going down with it.
All the best.
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